According to the principle of the State Drug Administration that formulating standards for pharmaceutical packaging materials is divided by material, one material (variety) for one standard, there are 43 standards for medicinal glass bottles that have been released and are to be released. According to the standard type, it is divided into three categories. The first category includes 23 product standards, of which 18 have been released, and 5 are planned to be released in 2004; the second category of test method standards includes 17, of which 10 have been released, and 7 are planned to be released in 2004. There are 3 basic standards in the third category, of which 1 has been released and 2 are to be released in 2004. The first category of product standards has 23 items, which are divided into 8 types according to product types, including 3 items of "Molded Injection Bottles", 3 items of "Controlled Injection Bottles", 3 items of "Glass Infusion Bottles", 3 items of "Molded Pharmaceutical Bottles" and 3 items of "Controlled Drugs". 3 items of "Controlled Oral Liquid Bottle", 3 items of "Controlled Oral Liquid Bottle", 2 items of "Ampoule" and 3 items of "Glass Medicinal Tube" (Note: This product is a semi-finished product for processing various controlled bottles and ampoules).
The bonding materials are divided into three categories, including 8 borosilicate glass, borosilicate glass including α= (4～5)×10 (- 6) K(- 1) (20～300 ℃) neutral glass and α= (3. 2～3. 4) × 10 (- 6) K(- 1) (20～300 ℃) 3. 3 borosilicate glass. This kind of glass material is international neutral glass, which is also commonly referred to as Class I glass or Class A material. 8 items of low borosilicate glass, low borosilicate glass is α= (6. 2～7. 5) × 10 (-6) K(-1) (20～300 ℃). This type of glass material is a quasi-neutral glass unique to China that cannot be in line with international standards, and is also commonly referred to as Class B material. 7 items of soda lime glass, soda lime glass is α= (7. 6 ~ 9. 0) × 10 (- 6) K (- 1) (20 ~ 300 ℃), this kind of glass material is generally vulcanized, and the surface is water-resistant The performance reaches level 2.
There are 17 test method standards in the second category. These test method standards basically cover various test items such as performance and indicators of various products of medicinal glass bottles, especially for the test of chemical properties of glass, new water resistance is added with reference to ISO standards. , The detection of alkali resistance and acid resistance provides more, more comprehensive and more scientific detection methods for the identification of chemical stability in order to adapt various products of medicinal glass bottles to drugs of different properties and dosage forms. Ensuring the quality of medicinal glass bottles and thus the quality of medicines will play an important role. In addition, the detection method for the leaching amount of harmful elements has been added to ensure the safety of medicinal glass bottles. The inspection method standards for medicinal glass bottles need to be further supplemented and improved. For example, the testing method of ampoules for alkali-resistant deflaking, the testing method for breaking force and the testing method for anti-freezing shock all have an important influence on the quality and application of medicinal glass bottles.
There are 3 basic standards in the third category, among which "Classification of Components of Medicinal Glass Bottles and Test Methods" refers to ISO 12775-1997 "Classification and Test Methods of Glass for Normal Mass Production". The bottle composition classification and its test method standards have a clear definition to distinguish the classification of glass materials in other industries. The other two basic standards respectively limit the harmful elements lead, cadmium, arsenic and antimony in glass materials to ensure the safety and effectiveness of various medicines.
